VOYAGER PAD, Revisited with Marc Bonaca, MD, MPH

The study author joins to highlight new ADA 2021 findings showing rivaroxaban's benefit for a subpopulation of diabetic patients.

Episode highlights

0:15 Intro
1:05 Returning to rivaroxaban
2:12 VOYAGER PAD Subgroup Analysis
4:42 Marc Bonaca, MD, MPH
29:13 Outro

About the study

Published: June 25, 2021

Design: VOYAGER PAD subgroup analysis

Population: 1,533 patients with critical limb ischemia (CLI), with or without diabetes

Assessment: 2.5 mg twice-daily rivaroxaban plus aspirin, versus placebo plus aspirin, for the reduction of composite acute limb ischemia, vascular-related major amputation, myocardial infarction, ischemic stroke, or cardiovascular-related death

Safety outcome: Major bleeding per Thrombolysis in Myocardial Infarction (TIMI); major bleeding per International Society on Thrombosis and Haemostasis (ISTH)

Findings: Rivaroxaban plus aspirin was associated with a 5.5% reduction in absolute composite endpoint risk reduction in patients with diabetes and CLI, with consistent safety outcomes.

Interesting note: Investigators observed 23% of patients with CLI and diabetes had experienced amputation, versus just 8% of patients with CLI.

The impact: “The risk in this population is really daunting. I mean, there’s an extremely high event rate, there’s a huge unmet need, and the efficacy of rivaroxaban is consistent and really associated with very large absolute risk reductions.”

New subgroup analyses from the VOYAGER PAD trial suggest 2.5 mg rivaroxaban plus aspirin provides consistent benefit in reducing risk of possibly fatal events in patients with critical limb ischemia (CLI) and diabetes.

The findings, presented by Marc Bonaca, MD, MPH, of CPC Clinical Research at the American Diabetes Association (ADA) 2021 Scientific Sessions this week, contribute to cardiovascular care on multiple levels.

First, it helps define the scope and scale of burden patients with comorbid diabetes and peripheral artery disease (PAD) face in limb and cardiac events—even when compared to patients with lone PAD.

Next—and most importantly—it establishes opportunity of care for millions of at-risk patients with a proven vascular therapy.

In the fourth episode of Heart Trials, Bonaca joined HCPLive during ADA 2021 to share perspective on the newest VOYAGER PAD analysis.

Along the way, Bonaca touched on the burdens of PAD on patients with diabetes, the continuation of VOYAGER PAD assessment, and the pursuit of patient-impacting clinical outcomes.

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